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510(k) Data Aggregation

    K Number
    K153494
    Device Name
    HQS Introducer (Model 2064-HQS)
    Manufacturer
    ALSEAL
    Date Cleared
    2016-08-25

    (265 days)

    Product Code
    DYB
    Regulation Number
    870.1340
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    HQS Introducer (Model 2064-HQS) is intended to be inserted in the vasculature to provide a conduit for the insertion of endovascular devices while minimizing blood loss associated with such insertions.

    Device Description

    Not Found

    AI/ML Overview

    This document is an FDA 510(k) clearance letter for a medical device called the "HQS Introducer (Model 2064-HQS)". It does not describe any acceptance criteria or studies related to AI/algorithm performance. Therefore, I cannot extract the requested information from the provided text.

    The document is a regulatory communication stating that the device is substantially equivalent to legally marketed predicate devices, allowing its commercialization. It discusses administrative details, regulatory compliance, and indications for use of the catheter introducer, but it does not contain information about an AI or algorithm-based device, its performance, or studies demonstrating its effectiveness.

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